HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LORBRENA safely and effectively. See full prescribing information for LORBRENA.
LORBRENA® (lorlatinib) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg or 100 mg. (3)
Concomitant use with strong CYP3A inducers. (4)
WARNINGS AND PRECAUTIONS
Most common adverse reactions (incidence ≥20%) are edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
LORBRENA® (lorlatinib) Highlights
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